COLORECTAL METASTATIC CANCER MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Sponsors
AZIENDA SANITARIA OSPEDALIERA S.CROCE E CARLE CUNEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hystologically confirmed CRC Metastatic disease previously treated with at least two lines of sistemic therapy. Measurable disease (RECIST criteria). At least one metastatic site suitable for irradiation. Signed informed consent. Geographical accessibility. Age ¿ 18 y.o. Karnofsky P.S. >=60% Life expectancy > 3 months. Adequate bone marrow function (Absolut Neutrophil count >=1,5 x 109/l, platelets>=¿100 x 109/l, hemoglobin >=¿10 g/dL). Adequate liver function: transaminases = 2.5 x upper limit of normality (ULN); bilirubin = 1.5 x ULN. Adequate renal function: Creatinine = ULN or creatinine clearance > 60 mL/min (Cockroft-Gault). Adequate contraception for childbearing potential women. Adequate cardiac function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Prior malignancies Prior organ transplantation Brain metastasis Autoimmune or allergic disorders Previous HBV or HCV infections Previous IL2 treatment Active steroid therapy Any active infection requiring specific treatment (Antibiotics, antimicotic, antiviral) Radiotherapy within 6 weeks before enrollment. Pregnant or lactating females. Other non-malignant uncontrolled systemic diseases or social conditions that would preclude trial entry in the opinion of the investigator. IL-2 treatment contraindications: 1. Hypersensitivity to the active ingredient or to any excipient. 2. Inadequate bone marrow function: WBC <2900 mm3 and/or HCT <30% and/or platelets count <90000 mm3. 3. Uncontrolled serous effusions (pleural, pericardic or peritoneal) 4. Blood Pressure <60 mmHg. 5. Pregnancy or breast feeding. 6. Active infections. 7. Brain metastases. Cyclophosphamide treatment contraindications: 1. Cystitis. 2. Urinary Obstruction. 3. Inadequate bone marrow function: WBC <2900 mm3 and/or HCT <30% and/or platelets count <90000 mm3. 4. Active infections. 5. Pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective response rate;Secondary Objective: Toxicity Quality of Life (QoL) Progression Free Survival (PFS) Overall Survival (OS);Primary end point(s): Objective response rate;Timepoint(s) of evaluation of this end point: during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity; QoL; Progression Free Survival; Overall Survival;Timepoint(s) of evaluation of this end point: during treatment and during 4 weeks after the end of treatment; every cycle and at the end treatment; from study entry to first documented disease progression or death from any cause ; from study entry to death from any cause | — |
Countries
Italy
Contacts
Public ContactUFFICIO SPERIMENTAZIONI CLINICHE
AZIENDA OSPEDALIERA S. CROCE E CARLE DI CUNEO
Outcome results
None listed